A Randomized Trial Comparing Two Doses of Portion-Controlled Foods Within a Primary Care Weight Loss Program (PCPCWLS)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00907660
First received: May 20, 2009
Last updated: February 1, 2013
Last verified: August 2010
  Purpose

We hypothesize that individuals provided with 1 meal per day of portion-controlled foods (shakes and prepared entrees) will lose as much weight as individuals provided with 2 meals per day of portion-controlled foods. The study is designed to assess whether equal weight loss can be achieved at a lower cost to the health care system (or health care payer), with patients contributing some of the cost of their own treatment.


Condition Intervention Phase
Obesity
Behavioral: Weight loss counseling
Dietary Supplement: Portion-Controlled Foods
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Trial Comparing Two Doses of Portion-Controlled Foods Within a Primary Care Weight Loss Program

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Weight change [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health-related quality of life [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Waist circumference [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Body mass index [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: May 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Full Dose
Provision of 8 weight loss counseling sessions, calorie guide, pedometer, meal plan, and 2 meals per day of portion-controlled foods (shakes and entrees)
Behavioral: Weight loss counseling
Monitoring of weight; review of food and physical activity records; counseling to reduce calorie intake by 500-1000 calories per day
Other Names:
  • Dietary counseling
  • Behavior modification
  • Diet and exercise
Dietary Supplement: Portion-Controlled Foods
Consumption of shakes, meal bars, and prepared entrees for 2 out of 3 meals per day during the 14 weeks of the study. "Full dose" patients are provided with both meals by the study; "half dose" patients are provided with one out of two meals by the study.
Other Name: Meal replacements
Experimental: Half dose
Provision of 8 weight loss counseling sessions, calorie guide, pedometer, meal plan, and 1 meal per day of portion-controlled foods (shakes and entrees)
Behavioral: Weight loss counseling
Monitoring of weight; review of food and physical activity records; counseling to reduce calorie intake by 500-1000 calories per day
Other Names:
  • Dietary counseling
  • Behavior modification
  • Diet and exercise
Dietary Supplement: Portion-Controlled Foods
Consumption of shakes, meal bars, and prepared entrees for 2 out of 3 meals per day during the 14 weeks of the study. "Full dose" patients are provided with both meals by the study; "half dose" patients are provided with one out of two meals by the study.
Other Name: Meal replacements

Detailed Description:

The study has two goals. First, it will assess the efficacy of a weight loss program, using a combination of counseling by peer weight coaches and portion-controlled foods. Second, the study will test the effect of varying the "dose" of portion-controlled foods provided to patients by randomly assigning individuals to receive half or all of the food required to follow a meal replacement regimen. The primary endpoint of the study will be weight change. Secondary endpoints will include adherence to the recommended eating plan, health-related quality of life, as well as changes in waist circumference and blood pressure. The provision of "half-dose" portion-controlled foods (1 meal per day) is hypothesized to be non-inferior to provision of "full-dose" (2 meals per day). The goal of non-inferiority is important because it can demonstrate that health care payers wishing to support weight loss programs can achieve equivalent results at a lower cost. All patients have the choice regarding their use of portion-controlled foods in the study, and no patients will be asked to leave the study because of non-adherence.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients from the University Medicine Denver, University Medicine Anschutz, and A.F. Williams clinics meeting the following criteria
  • Age 18 or older
  • Able to keep a food record for 3 days prior to study entry
  • Able to give informed consent
  • Willing to accept randomization to either treatment condition, to attend all sessions, and to complete study-related assessments
  • Body mass index (BMI) ≥ 30 kg/m2 and < 50 kg/m2
  • Elevated waist circumference (≥ 88 cm for women, ≥ 102 cm for men) + any one of the following:
  • Glucose intolerance (fasting glucose ≥ 100 or non-fasting glucose ≥ 140, including type 2 diabetes); individuals taking medications for diabetes qualify automatically
  • Elevated blood pressure (≥130/85), including hypertension (≥140/90); individuals taking anti-hypertensive medication qualify automatically
  • Hypertriglyceridemia (TG ≥ 150); individuals taking lipid-lowering medications qualify automatically
  • Decreased high-density lipoprotein (HDL) cholesterol (< 40 for men, < 50 for women)
  • Obstructive sleep apnea

Exclusion Criteria:

  • Medical conditions in which significant weight loss is normally contraindicated (e.g. pregnancy, congestive heart failure requiring diuretics, poorly controlled diabetes, Stage 4 or 5 chronic kidney disease, clinically evident cirrhosis, other severe internal organ disease); exceptions may be made if a referring physician documents that it is safe and appropriate for the individual to lose weight
  • Treated for cancer within the past 5 years, except for basal cell or squamous cell skin cancer; exceptions may be made with written permission from a physician
  • Weight gain or loss of ≥5% of weight in the past 6 months; patients who have not been weight stable may be re-screened in 3 months
  • Concurrent use of corticosteroids or second-generation antipsychotic medications (exceptions may be made for individuals using these medications who have been weight stable for 6 months)
  • Psychiatric diagnoses likely to affect adherence to a research study protocol (e.g., poorly controlled schizophrenia, active substance abuse)
  • Prior or planned bariatric surgery
  • Participation in an organized weight loss program (e.g., Weight Watchers) at the time of enrollment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00907660

Locations
United States, Colorado
Center for Human Nutrition
Denver, Colorado, United States, 80220
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Adam G Tsai, MD, MSCE University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00907660     History of Changes
Other Study ID Numbers: 09-0054, K24DK065018
Study First Received: May 20, 2009
Last Updated: February 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
Obesity
Weight loss
Meal replacements
Health services research

Additional relevant MeSH terms:
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on October 01, 2014